Frequency Therapeutics — Hearing Loss Regeneration

#8,821
Lucifer said:
In the Fireside chat did they actually specifically say that after Phase 2a there will be one more pivotal phase before approval?

Does that mean it's most likely going to be Phase 3?
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At around 31min, LeBel says, "Assuming we have a positive readout from the Phase 2A, our intent is to go to the FDA to discuss with them to go Pivotal with the next phase."
 
#8,823
Fightthearmy said:
"Pivotal" sometimes means phase 2b, sometimes phase 3. What's with these stupid ambiguous terms...
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For all intents and purposes, it doesn't matter if the final study will be a 2b or 3, though. Either way, the plan is to take what they learned about dosing in 2a and give it to a wider patient population and submit the results to the FDA for approval.
 
#8,825
FGG said:
For all intents and purposes, it doesn't matter if the final study will be a 2b or 3, though. Either way, the plan is to take what they learned about dosing in 2a and give it to a wider patient population and submit the results to the FDA for approval.
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Wouldn't it be better for them to skip Phase 2b and go straight to Phase 3 though? Don't the FDA state they must have a Phase 3 clinical trial before releasing the drug into the market?

If it's Phase 2b next then wouldn't they have to do a Phase 3 clinical trial?

Can they call it Phase 2b and still release it after the Phase 2b clinical trials are done?
 
#8,826
Lucifer said:
Wouldn't it be better for them to skip Phase 2b and go straight to Phase 3 though? Don't the FDA state they must have a Phase 3 clinical trial before releasing the drug into the market?

If it's Phase 2b next then wouldn't they have to do a Phase 3 clinical trial?

Can they call it Phase 2b and still release it after the Phase 2b clinical trials are done?
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A pivotal trial is the submitting trial, it doesn't matter if it's 2b or 3. Makes no difference.
 
#8,829
Well, I really had to Google it and...

https://www.lawinsider.com/dictionary/pivotal-clinical-trial

My favourite:

Pivotal Clinical Trial means (a) a Phase III Trial or, (b) a Phase II Trial to the extent: (i) in the United States, the protocol for that Phase II Trial shall have been reviewed by the FDA under its current Special Protocol Assessment Guidelines (or equivalent guidelines issued in the future), and any comments from the FDA on that protocol are incorporated in the final protocol for that Phase II Trial or are resolved to the FDA's satisfaction as evidenced by further written communications from the FDA; or (ii) a process with a comparable result – acceptance of a Phase II Trial protocol as "potentially pivotal" – has occurred with the EMA or other Regulatory Authorities in the EU; or (iii) based on the results of that Phase II Trial, either the FDA or the EMA has determined that the Phase II Trial can be considered as a pivotal clinical trial for purposes of obtaining Regulatory Approval.
 
#8,830
FGG said:
A pivotal trial is the submitting trial, it doesn't matter if it's 2b or 3. Makes no difference.
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They could technically release right now if they so chose.
That said, it makes a difference if Frequency claims that they want to wait the result of phase 3 before releasing the drug to the market. Time will tell.
 
#8,831
I also found it interesting they said Astellas have begun talks with the authorities in their territories. Let's hope if Phase 2a goes well, we'll see a Phase 2b (or Phase 3) in Europa and/or Asia.
 
#8,832
Lucifer said:
So you are saying even if it's Phase 2b next they could still release the drug after Phase 2b is done?
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A pivotal trial intends to provide the ultimate evidence and data that the FDA uses to decide whether or not to approve a potential new medicine.

So theoretically, they could release the drug after Phase 2b. However, it usually isn't as simple as that. Before going to market, production needs to be ramped up and the proper logistics need to be put into place—and much more.

Moreover, FREQ might still want to conduct additional trials if they have a contractual incentive to hit certain milestone payments.
 
#8,833
Mathieulh said:
They could technically release right now if they so chose.
That said, it makes a difference if Frequency claims that they want to wait the result of phase 3 before releasing the drug to the market. Time will tell.
Click to expand...
They could allow compassionate use which isn't the same as release but allows doctors to petition for individual cases.
 
#8,834
Fields said:
A pivotal trial intends to provide the ultimate evidence and data that the FDA uses to decide whether or not to approve a potential new medicine.

So theoretically, they could release the drug after Phase 2b. However, it usually isn't as simple as that. Before going to market, production needs to be ramped up and the proper logistics need to be put into place—and much more.

Moreover, FREQ might still want to conduct additional trials if they have a contractual incentive to hit certain milestone payments.
Click to expand...
From the FREQ 10-K filed in March:

Under our agreement with Astellas, Astellas is responsible for the development and commercialization of FX-322 outside of the United States. As consideration for the licensed rights under the Astellas Agreement, Astellas paid us an upfront payment of $80.0 million in July 2019 and has agreed to pay potential development milestone payments of up to $230.0 million. Specifically, we would receive development milestone payments of $65.0 million and $25.0 million upon the first dosing of a patient in a Phase 2b clinical trial for SNHL in Europe and Asia, respectively, and $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical trial for SNHL in Europe and Asia, respectively. If the Astellas licensed products are successfully commercialized, we would be eligible for up to $315.0 million in potential commercial milestone payments plus tiered royalties on any future product sales ranging from low- to mid-teen percentages.

-----

Astellas is paying Frequency for jointly meeting each development milestone outside of the US. The agreement is clearly structured to gain the ultimate benefit at the commercial milestone. There's not clear contractual wording in the 10-K that FX-322 cannot "skip" a trial.

The key word I am seeing here is "milestone" I am not a lawyer; but if FX-322 goes from Phase 2A -> Phase 3, they technically achieved the 2B milestone by skipping it; and would receive the benefit.

In my opinion, the way it is structured, the emphasis is to get to that commercial milestone + royalties.

Also, there's no mention that US development and International development could be asynchronous. I don't know if this is possible; where FREQ starts a US Phase 3, while Astellas is conducting a 2B in a EU/Asia country.
 
#8,835
index.jpg
 
#8,836
Diesel said:
From the FREQ 10-K filed in March:

Under our agreement with Astellas, Astellas is responsible for the development and commercialization of FX-322 outside of the United States. As consideration for the licensed rights under the Astellas Agreement, Astellas paid us an upfront payment of $80.0 million in July 2019 and has agreed to pay potential development milestone payments of up to $230.0 million. Specifically, we would receive development milestone payments of $65.0 million and $25.0 million upon the first dosing of a patient in a Phase 2b clinical trial for SNHL in Europe and Asia, respectively, and $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical trial for SNHL in Europe and Asia, respectively. If the Astellas licensed products are successfully commercialized, we would be eligible for up to $315.0 million in potential commercial milestone payments plus tiered royalties on any future product sales ranging from low- to mid-teen percentages.

-----

Astellas is paying Frequency for jointly meeting each development milestone outside of the US. The agreement is clearly structured to gain the ultimate benefit at the commercial milestone. There's not clear contractual wording in the 10-K that FX-322 cannot "skip" a trial.

The key word I am seeing here is "milestone" I am not a lawyer; but if FX-322 goes from Phase 2A -> Phase 3, they technically achieved the 2B milestone by skipping it; and would receive the benefit.

In my opinion, the way it is structured, the emphasis is to get to that commercial milestone + royalties.

Also, there's no mention that US development and International development could be asynchronous. I don't know if this is possible; where FREQ starts a US Phase 3, while Astellas is conducting a 2B in a EU/Asia country.
Click to expand...
With the clinical trials outside USA I reckon if they did Phase 2b then release it Frequency Therapeutics should still get the royalties from Phase 3 and vice versa if they skipped a Phase 2b trial and went to Phase 3.
 
#8,841
Danad said:
Not sure if anyone previously posted this study. Again, we see the positive effects of hearing restoration on tinnitus:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5971248/

View attachment 39313
Click to expand...
Interesting research! It would be so revealing for this type of research if Frequency can release some type of aggregate high-frequency audiogram data for Phase 2A participants with Tinnitus ...

They may be able to draw a connection between FX-322 restoring high-frequency cells. The result should be that improving high-frequency hearing on the extended audiogram, results in a reduced TFI score.
 
#8,850
NewLionel said:
Looks great... especially the phase graph.
Click to expand...
Yes, let's hope this 20% progress of the chart for phase 2 does not correspond 1:1 to the last 9 months the trial is already running. If this was the case however the trial would take nearly 4 years.
 

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